Is Sacubitril-valsartan Superior to Dapagliflozin in Improving Myocardial Function Performance

NCT ID: NCT06090487

Last Updated: 2024-09-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-01
• Study Completion Date: 2024-03-01

Brief Summary

The aim of this study is to assess whether sacubitril-valsartan is more effective than dapagliflozin in improving function, myocardial performance in patients undergoing CABG operation or not

Detailed Description

Coronary revascularization has matured as a field since coronary artery bypass grafting (CABG) was first developed over 50 years ago, with diagnostic and treatment methods have advanced dramatically. CABG remains the standard of care for obstructive coronary artery disease, particularly for patients with multivessel disease or diabetes. (1) Despite significant therapeutic advances, patients with chronic heart failure (HF) remain at high risk for HF progression and death. Sacubitril/valsartan (previously known as LCZ696) is a first-in-class medicine that contains a neprilysin (NEP) inhibitor (sacubitril) and an angiotensin II (Ang-II) receptor blocker (valsartan). NEP is an endopeptidase that metabolizes different vasoactive peptides including natriuretic peptides, bradykinin and Ang-II. In consequence, its inhibition increases mainly the levels of both, natriuretic peptides (promoting diuresis, natriuresis and vasodilatation) and Ang-II whose effects are blocked by the angiotensin receptor blocker, valsartan (reducing vasoconstriction and aldosterone release). (2) Sacubitril-valsartan has been used selectively in patients undergoing coronary artery bypass grafting (CABG) and ischemic cardiomyopathy due to safety concerns. In a prospective observational study done by Narayan and his colleagues in Patients with Ischemic Cardiomyopathy Undergoing Off-Pump Coronary Artery Bypass Grafting Primary outcome was tolerability and safety profile. Thirty consecutive patients undergoing CABG with EF <40% were included. No mortality or readmissions occurred during 6 months' follow-up. One patient only experienced hypotension requiring discontinuation. Mild elevation in blood urea nitrogen, so Sacubitril-valsartan is well tolerated in patients with reduced EF undergoing CABG and proved its safety and efficacy. (3) Dapagliflozin is a highly potent, reversible and selective sodium-glucose cotransporter-2 inhibitor indicated worldwide for the treatment of type 2 diabetes. In numerous well-designed clinical studies dapagliflozin as monotherapy and combination therapy with other antihyperglycemic agents provided effective glycemic control and reduced bodyweight and blood pressure (BP) across a broad spectrum of patients. Dapagliflozin reduced the rate of cardiovascular (CV) death or hospitalization for heart failure (HF), did not adversely affect major adverse cardiovascular events (MACE) and possibly reduced progression of renal disease in patients with established atherosclerotic CV disease (CVD) or multiple risk factors for CVD. (4)

Conditions

Heart Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: SINGLE

Study Groups

Group sacubitril: (study group)

This group includes (15) patients who will have 200 mg twice daily oral (5) sacubitril-valsartan 1 month before the operation.

Group Type: OTHER

myocardial function after surgery

Intervention Type: DIAGNOSTIC_TEST

This group includes (15) patients who will have 200 mg twice daily oral (5) sacubitril-valsartan 1 month before the operation. transthoracic echo will be done before and after surgery, also total dose if inoptropic drugs will be noted

Group dapagliflozin: (control group):

This group includes (15) patients who will have a 10 mg single oral dose (4) 1 month before the operation.

Group Type: OTHER

myocardial function after surgery

Intervention Type: DIAGNOSTIC_TEST

This group includes (15) patients who will have 200 mg twice daily oral (5) sacubitril-valsartan 1 month before the operation. transthoracic echo will be done before and after surgery, also total dose if inoptropic drugs will be noted

Interventions

myocardial function after surgery

This group includes (15) patients who will have 200 mg twice daily oral (5) sacubitril-valsartan 1 month before the operation. transthoracic echo will be done before and after surgery, also total dose if inoptropic drugs will be noted

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

1. Age between 50 to 70 years old

2. DM type 2

3. ASA 3

4. Only 2 coronary grafts

5. Elective surgery

6. Bypass time less than 1 hour

7. Senior staff cardiothoracic

Exclusion Criteria

1. ASA 4 or more

2. Emergency surgery

3. Bypass time of more than 1 hour

4. Coronary grafts of more than 2

5. Any allergy to the used drugs

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ain Shams University

OTHER

Sponsor Role: lead

Responsible Party

Amr Gaber

lecturer clinical doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

amr gaber, lecturer

Role: PRINCIPAL_INVESTIGATOR

Ain Shams University

Locations

Ain Shams University

Cairo, , Egypt

Countries

Egypt

Other Identifiers

CABG

Identifier Type: -

Identifier Source: org_study_id